A clinical research administrator, also referred to as a clinical monitor or trial monitor, is a health-care professional that performs activities related to medical research, particularly clinical trials. Clinical research administrators work in various settings, such as pharmaceutical companies, medical research institutes and government agencies.
A key responsibility of a clinical research administrator is to monitor clinical trials. In some examples, an administrator may work directly with a sponsor company of a clinical trial, as an independent freelancer or for a contract research organization. A clinical research administrator is typically responsible for a number of duties across multiple locations that involve a large amount of time and coordination.
Several clinical trials are often conducted at a clinical site (medical practice office, hospital or specialized clinic) and require periodic participation by the patients over a long period of time, from as little as a few days to many years. The patients typically come to the clinical site numerous times for periods of time to receive treatments and be tested to determine the results of the treatments.
Clinical research costs are skyrocketing due to inefficient patient recruitment, delays due to patient enrollment problems, clinical trial management and
An increase in the number of trials across the industry means that more and more drug companies sponsoring clinical trials need to attract the best-performing CROs, clinical sites, and physician investigators (PIs) to increase their odds for success, which only drives prices for CRO services even higher. Likewise, the number of trials at each clinical research site is increasing while the number of clinical research sites is also growing. With more research sites being used for a particular research trial, as well as, more research trials at a particular research site, the costs and complexity associated with recruitment, monitoring, management, and reporting are growing. Accordingly, clinical trial sponsors and clinical (or contract) research organizations (CROs) are desperate for solutions to improve and streamline the clinical trial process.
Conventional tools available for managing clinical trials employ legacy technology and are insufficient to scale with the growth and complexity of the clinical research industry.
Many such conventional systems fail to harness the full capabilities of technology such as mobile devices, location based information, and the ability to track location through and push messages to mobile devices to effectively manage onsite activities and gain insights about participants.
For instance, modern personal mobile devices and wearable technology (e.g., smartphone, tablet personal computer (PC), smartwatch) afford users an unprecedented level of connectivity. Users are able to upload and download data at virtually any location. However, conventional means of conducting research (e.g., clinical studies or trials) still confine the process both geographically and temporally. A study participant (e.g., patient) rarely interacts with study organizers (e.g., medical researchers) outside of designated facilities (e.g., laboratory, hospital) and scheduled appointments. Consequently, both participants and organizers may fail to capture and exchange valuable data throughout the duration of the research.
Clinical research administrators need modern tool to effectively monitor and manage compliance with clinical trial protocols, checks clinical site activities, site inspections, reviews case report forms, as well as communicate with clinical research coordinators. Clinical research administrators play an important role in assuring the protection of the rights, safety and wellbeing of human study subjects. Clinical research tools need to protect the scientific integrity of collected data collected and assure that adverse events are correctly documented and reported.